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临床试验/NCT02202109
NCT02202109已完成不适用

Addressing Cervical Cancer Disparity in South Florida: CBPR in Action

University of Miami2 个研究点 分布在 1 个国家目标入组 602 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
602
试验地点
2
主要终点
Number of Participants Completing a Self-sampling Test

研究概览

简要总结

The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Haitian, Hispanic, or African American
  • Ages 30-65 years
  • Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade

排除标准

  • Women who report having had a hysterectomy
  • Women who have a history of cervical cancer
  • Women who plan to move outside of Miami-Dade county during the next six months
  • Women who are enrolled in any other cancer prevention/outreach related study
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

研究组 & 干预措施

CHWs facilitated Self-Sampling

Active Comparator

CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test

干预措施: CHW and Self-sampling for Cervical Cancer (Behavioral)

Mailed Self-Sampler

Active Comparator

Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone

干预措施: Mailed Self Sampler (Behavioral)

结局指标

主要结局

Number of Participants Completing a Self-sampling Test

时间窗: 2 to 6 months

The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.

次要结局

  • Proportion of Change in Cervical Cancer Knowledge Among Participants(Baseline, 6 months)
  • Proportion of Participants With a Change in Access to Care(Baseline, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erin Kobetz-Kerman

Associate Professor

University of Miami

研究点 (2)

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